Phase II Evaluation of AHCC for the Eradication of HPV Infections

Inclusion Criteria

• •• Women over 30 years of age who have a HPV positive test and normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia within three months of study entry.
• •* Women must have had 2 other HPV positive tests with normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia
• •* 1 greater than 6 months and no more than 18 months prior to study entry
• •* 1 greater than 24 months prior to study entry.
• •* Women of child bearing potential must have a negative urine pregnancy test within 7 days of therapy start.
• •* Patients must have adequate hematologic, renal, and hepatic function as noted from labs within the previous 12 months: ANC \>/= 1,500 cells/mm3, platelets 100,000 \>/= cells/mm3; Creatinine clearance\>/= 60 mL/min (estimated by Cockcroft Gault equation), total bilirubin, SGPT, SGOT, and alkaline phosphatase \</= 1.5 times normal.
• •* Patients of child-bearing age must agree to use effective methods of contraception (oral contraceptives, condoms, etc.) while on study.